The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015

The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015

Date: 25 September 2017

Patient reports contribute to signal detection. This was demonstrated by a study by van Hunsel et al. which was recently published.

In the Netherlands patient reports are important in identifying signals, especially signals related to generic substitution and psychiatric adverse drug reactions (ADRs). In the present study, van Hunsel et al. aimed to investigate the contribution of patient reports to signals detected by the Netherlands Pharmacovigilance Centre Lareb, and to determine if there are certain types of signals where patient reports add a distinct contribution.

They analyzed 150 signals detected at the Netherlands Pharmacovigilance Centre Lareb between 2010 and 2015 and their corresponding reports (1691 reports)with regards to a number of different characteristics such as type of reporter, type of drug and type of ADR.

26% of all ADR reports contributing to safety signals were reported by patients, and in one third the patient reports in the signals contained one or more terms listed as important medical events. ADRs on this list can for instance lead to hospitalization or have other serious consequences. The study also shows that reports from healthcare professionals (HCP) are also still very valuable for signal detection. Almost 4% of all HCP reports received contributed to a signal in this time period, for patients this was 2% and for reports received by marketing autorisation holders 0.2%.